Elucidating the Mechanism of Remission of Type 2 Diabetes in Morbid Obese Patients After Bariatric Surgery
NCT ID: NCT03038373
Last Updated: 2022-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2012-04-30
2024-12-31
Brief Summary
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Detailed Description
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Briefly the study will be explained to the each participant, and after his/her agreement, the informed Consent Form will be deliver to him/her for completion and signature. Within a week before surgery each enrolled participant of group I and II will be subjected to a medical questionnaire and other routine laboratory analyses before surgery such as fasting glucose, liver, renal, lipid and coagulation profiles. At this time a Mixed Meal Tolerance Test (MMTT) will be performed and blood samples will be collected for further analysis as it is described in the protocol.
Participants in group I and II will be admitted at Dasman Diabetes Institute for post-surgery follow up, performing MMTT, and donating blood samples on days 07, 15, 30, 60, 90, 180, and 360 post-surgery. Adipose, muscle biopsies, and a sample from remnant surgical tissue from these participants will be harvested during of the LSG (days 0). Participants in group I will be asked to monitor their fasting blood glucose level everyday at early morning and the dose of anti-hyperglycemia medications will be adjusted by the recommendation provided by the physician member of team. This data will be recorded as their continuous blood glucose monitoring.
Group III and IV participants, as control groups with no surgical intervention, will be subjected to the medical questionnaire and other routine laboratory analyses and MMTT in just one visit.
All demographic and clinical information collected from the participants will be recorded in the information form identified by identification number (ID number). Only samples from the cases that do not have any post-surgery related complications or not have any emergency clinical condition will be used for genomics and proteomics analysis.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group I
Morbid Obese Type 2 Diabetics, undergo Laparoscopic Sleeve Gastrectomy
Laparoscopic Sleeve Gastrectomy
Laparoscopic Sleeve Gastrectomy will be conducted based on standard protocol.
Group II
Morbid Obese Non Diabetics, undergo Laparoscopic Sleeve Gastrectomy
Laparoscopic Sleeve Gastrectomy
Laparoscopic Sleeve Gastrectomy will be conducted based on standard protocol.
Group III
Lean Diabetics, No surgery
No interventions assigned to this group
Group IV
Lean Non Diabetics, No surgery
No interventions assigned to this group
Interventions
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Laparoscopic Sleeve Gastrectomy
Laparoscopic Sleeve Gastrectomy will be conducted based on standard protocol.
Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes \<5 years
* male and female,
* resident of Kuwait,
* who agreed to participate in the study
Exclusion Criteria
* malignancy,
* type 1 diabetes,
* type 2 diabetes with more than 5 years,
* and history with overt heart and/or kidney failure
18 Years
75 Years
ALL
Yes
Sponsors
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Kuwait University
OTHER
Dasman Diabetes Institute
OTHER
Responsible Party
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Principal Investigators
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Hossein Arefanian, PhD
Role: PRINCIPAL_INVESTIGATOR
Dasman Diabetes Institute
References
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Al Shawaf E, Al-Ozairi E, Al-Asfar F, Mohammad A, Al-Beloushi S, Devarajan S, Al-Mulla F, Abubaker J, Arefanian H. Atherogenic Index of Plasma (AIP) a Tool to Assess Changes in Cardiovascular Disease Risk Post Laparoscopic Sleeve Gastrectomy. J Diabetes Res. 2020 Aug 1;2020:2091341. doi: 10.1155/2020/2091341. eCollection 2020.
Other Identifiers
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RA-2011-014
Identifier Type: -
Identifier Source: org_study_id
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